ES2374234B1 - SYSTEM OF ANALYSIS AND MANAGEMENT OF SURGICAL IMAGES. - Google Patents

Abstract

Surgical image analysis and management system. # A surgical image analysis and management system is described that allows monitoring and recording in real time all the activity of an operating room or complex medical-surgical environment by integrating images or video signals from devices commonly used in the operating room, video signals from computers and computer equipment used in the operating room, images of radiological studies and clinical history data from hospital networks or conventional supports and signals from conventional video cameras, without interfere in clinical activity.

Description

System of analysis and management of surgical images.

Object of the invention

The present invention describes a system of analysis and management of surgical images (SAGIQ) that allows monitoring and recording in real time all the activity of an operating room or complex medical-surgical environment by integrating i) images (video signals) from the devices commonly used in the operating room (surgical microscopes, ultrasound, endoscopes, navigators, X-ray equipment, computerized tomographs and resonators, respirators, ...), ii) video signals from computers and computer equipment used in the operating room ( intraoperative neurophysiological monitoring systems such as electroencephalographs and electromyographs), images of radiological studies and clinical history data from hospital networks or conventional supports and iii) signals (images) from conventional video cameras, without interfering with clinical activity, as well as dynamically manage the signals in real time video from different cameras and surgical devices, so that each professional present in the operating room can choose which image to visualize at each moment. Likewise, combinations of multiple images (video signals) can be generated on the same screen, in real time, and both the images coming from the cameras and those coming from the devices and the combined image can be sent to different monitors installed in the operating room or to the outside of it, for retransmission or Internet connection. The presented system also allows the integration of audio signals from microphones available inside the operating room, generating a mixed signal for sending abroad as well as receiving audio signals from outside the operating room.

Background of the invention

There are surgical operations in which a large number of professionals intervene, each of which is responsible for only part of the intervention, and therefore the medical-surgical information that each of them requires to carry out their work is different . This medical-surgical information can include both data provided by elements such as respirators, ultrasound scanners, etc. as real images of the operation itself (endoscopes, surgical microscopes, ...). However, access to such medical and surgical information is often difficult due to the large number of people and devices present in the operating room that interfere with the communication lines of professionals with each other. For this reason, it is usual to have video cameras that collect information on different aspects of operations. However, problems of accessibility to medical-surgical information may still arise at specific times during the interventions. Additionally, it is useful for the subsequent and / or real-time evaluation of the operations to record the information provided by the cameras or other elements for later analysis, as well as offer the possibility of transmitting the operation live for instant viewing by students or other doctors and professionals. In long-term surgical interventions, ergonomics in the vision of multiple very demanding imaging sources is a very important factor in minimizing the observer's visual fatigue (surgeons, anesthesiologists, nurses and other professionals). Also, in interventions with multiple teams of professionals working simultaneously in the operating room, the coordination and synchrony between them is greatly improved if everyone has the possibility to observe, in real time, the activities that are taking place developed by the other professionals.

To solve these problems, there are some surgical image management systems that centralize all the information in a device in order to improve its accessibility. An example of a history of the invention is the design and assembly project of the University of California (UCLA) and RBB Architects Inc. of the so-called “operating rooms of the future” in a new hospital, referred to in the “Annual Seminal on Imaging and Informatics (Arrowhead, California, 2004), which describes a device that allows centralized control by the surgeon of all devices and the use of multiple flat screens in the operating room. However, it is inferred from the description of this system that it is a digitalized system, with control and operation through computer systems of very high cost and performance. These integrated operating room systems are the so-called “smart operating rooms”, in which the centralized control systems of the equipment are integrated into the architectural design of the operating rooms.

Some more known systems are Endoalpha (Olympus), Averpit (Steris), Patient-Aware OR (Karl Storz and LiveData), BrainSuite NET (Brainlab), Hybrid Rooom (Phillips in cooperation with Steris, Skytron and Brainlab) , the Skyvision (Skytron) or the Smart OR (ConMed), among others. However, these systems have the following main drawbacks:

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They are fixed systems, that is, they cannot be moved from one operating room to another according to the needs of the institution and / or the professionals.

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These are extremely specific systems, which does not allow changing the use of the system according to the nature of the invention (neurosurgery, fetal surgery, general surgery, etc.)

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They require a high deployment time, from the moment in which the installation of the system is accepted until its commissioning, months pass.

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The investment, both in facilities and in training, is very high.

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They are based on software management, which makes them extremely dependent on specialized operators and integrated communication systems, but not always integrable into other information systems.

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They are based on the acquisition of solution packs that include the integration of sources and data but also the sources of images and data.

Finally, the applicants of the present invention are the holders of the patent P2264845. This patent describes a system of analysis and management of surgical images consisting of two modules to which the various image and signal generating devices are connected.

Consequently, there is still a need for a system that allows adequate control and access to all surgical information in an operating room and at the same time is simple, economical and versatile.

Description of the invention

The system of the present invention allows to monitor and record in real time all the activity of an operating room by integrating the images provided by the usual operating room systems and conventional video cameras, without interfering in clinical activity and without requiring technological knowledge advanced. In addition, an important advantage of the present invention is that it is transferable, since it is physically a system mounted on a platform with wheels that can be moved from one operating room to another depending on the specific needs of each surgical intervention. This feature avoids the need to have a single operating room specially adapted for the use of the present invention, so it can be used in consecutive interventions in different operating rooms, even separated by considerable distances, unlike existing systems that due to its enormous complexity They are installed permanently.

In addition, the system of the present invention is compact, although with a modular structure that makes it possible to distinguish control elements from viewing elements, so that possible incidents in any of the internal devices do not affect the rest. Note that the viewing union with control could lead to total system shutdown in case of failure.

Another important advantage of the system of the invention is the possibility of allowing both digital and analog connections. Although digital systems have proven their versatility and comfort widely compared to analog systems, the current reality in the development environment of the system of the invention, the Spanish healthcare system, dictates that the vast majority of available equipment are analog in their connections . The ease and low cost of connecting existing equipment is a very significant factor.

The control of the system during surgical interventions is carried out by means of a remote control connected by cable and, possibly, by a support computer through a standard pointing device (mouse), although the computer is not essential for its operation. The information is presented graphically on a screen located above the system, thus reducing complexity and allowing dynamic real-time management of video signals from different sources so that each professional can choose at any time which image they need to visualize. Similarly, the system allows to integrate and control audio signals in and out of the operating room. In addition, thanks to the possibility of configuring the entire system only once, time stability is ensured in the task of recording as many interventions as desired, without the need for complicated prior or subsequent processes that hinder work within the operating room.

The invention describes a surgical image analysis and management system that manages 12 PAL channels and 4 VGA channels containing surgical information or complex medical-surgical environments. Said medical-surgical information may consist of images or optical signals (from microscope, endoscope, surgical field cameras, helmet microcameras, environment cameras or any other type of camera that generates an output video signal), radiological (images or data from computerized tomography, magnetic resonance imaging, ultrasound, browsers, positron emission tomography or any other techniques) and data (signals from monitoring systems, such as anesthesia and neurophysiology monitors such as electroencephalographs, electromyographs, stimulators or others). The system comprises the following elements:

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A VGA / PAL conversion device that converts the 4 source VGA channels into 4 PAL channels. It can be a single device with 4 inputs / outputs, or four devices arranged in parallel.

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A 16-channel video switching matrix, preferably a Sierra Lassen XL model, which receives the 12 source PAL channels and the 4 outgoing PAL channels of the VGA / PAL conversion device and sends them to certain output PAL channels. This device is manageable by medical personnel to choose which images to send to the output channels, for example by means of a remote control and / or through a support PC.

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A multiple image processor, preferably a Kaleido-Alto model, connected to 10 of the output PAL channels of the video switching matrix, which produces a multiple digital video image that simultaneously contains the corresponding 10 images and sends it to a multichannel monitor for viewing. Multiple digital video can be in any of the VGA, DVI, SDI or similar formats. Since the images transmitted by each of said 10 output PAL channels of the switching matrix are configurable by medical personnel, the system allows the combination of 10 images that best suits each need to be created.

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Six monitors connected to the remaining 6 PAL output channels of the video switching matrix, and that allow medical personnel to visualize in real time the images of said channels. In a manner similar to that described above, medical personnel can choose which images contain said 6 PAL output channels of the switching matrix, so that each professional has real-time access to the image that most interests them at all times. The monitors can be arranged inside the operating room, or the signal can be sent abroad, for example to a classroom or to a conference room, for training or dissemination.

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A recording device, which stores the multiple digital video image and an output channel of the switching matrix, leaving the images stored for further consultation or study. Preferably, the system of the invention comprises an additional screen that allows the two channels being recorded to be displayed, both at the input and output of the recording equipment. This configuration not only allows you to know at any time what images are being recorded, but also to access previously recorded images even during the operation itself if necessary. The recording equipment is preferably formed by two professional hard disk video recorders, each of which respectively stores the video files of the previous PAL channel and the multiple digital video channel on a removable hard disk that can be accessed later by USB port.

According to a preferred embodiment, the system further comprises a support personal computer (PC) connected to the video switching matrix and the multiple image processor to allow its handling and configuration in real time. Even without it, the professionals present in the operating room can operate the switching matrix and the multiple image processor to choose which image is displayed on each of the monitors according to their needs at any time, given that the analysis system of The present invention is designed so that it can operate independently of the support computer. This computer, however, facilitates the creation of new operating scenarios and the management of the different elements (video matrix and multiple image generator).

Furthermore, according to a preferred embodiment of the invention, the system comprises a remote control that allows the video switching matrix to be operated remotely.

Additionally, the system of the invention has an audio management device that incorporates a front connection of audio inputs and outputs with the possibility of silencing them. The audio inputs from the operating room and outside are connected to this management device, allowing two-way communication between the two scenarios. The device also has line outputs to attack speakers both in the operating room and outside it, as well as an additional recording system that stores all audio signals. The connection circuits of the audio management device are completely independent from those of video.

The system also contains a modular wiring subsystem for connection with the different elements that provide the input channel signals. This wiring, consisting of at least two cable branches, collected under a pipe and terminated in junction boxes, allows the system to be deployed quickly and easily in unusual environments.

This system also allows its use in confined spaces, since it can outsource most of the imaging systems that do not necessarily require the introduction into the operating room, such as human neurophysiology teams, second surgical or anesthetic teams or coordinate with other surgical teams in others. operating rooms in cases of combined surgeries (twins, transplants, bank surgeries ...). This concept allows, therefore, to optimize surgical spaces and times, such expensive and scarce elements at the same time to the maximum, without the need for additional investments and in real time.

Finally, although they are not explicitly described, it is understood that the system also includes all the necessary wiring to make the connections between the different elements that comprise it, as well as power supplies, transformers, etc. necessary to feed these elements.

Brief description of the drawings

Fig. 1 shows a schematic of the surgical image analysis and management system according to the present invention.

Fig. 2 shows a perspective view of the system of the present invention where the connection chart is appreciated.

Fig. 3 shows a view of the wiring of the system of the present invention where the connections are appreciated.

Preferred Embodiment of the Invention

An example of a system (1) according to the present invention is described below with reference to the attached figures. The system (1) is designed to receive 12 signals in PALy4 format in VGA format, represented at the top of the fi gure, coming from all the usual operating room and intraoperative devices, such as surgical microscopes (conventional or helmet), endoscopes, ultrasound scanners, respirators, neurophysiology systems, radiology equipment, surgical field cameras, operating room and computer environment cameras, both with video and VGA outputs. Some entries may be duplicated (for example, ultrasound and respirators) to allow simultaneous monitoring of fetal surgeries with mother and two fetuses ("twin" interventions). In any case, an example of con fi guration of the inputs for a particular case could be:

VGA1

Respirator.

VGA2

Echograph

VGA3

Computer with CT / RM study.

VGA4

Neurophysiological ICP monitoring.

PAL1

Endoscope

PAL2

Helmet Microscope

PAL3

Environment camera

PAL4

Exoscope

PAL5

Surgical Field Camera

PAL6

Browser.

PAL7-12

Channels for additional use.

These signals, once the four VGA signals have been transformed into PAL signals by means of the VGA / PAL conversion device (2), constitute the inputs to a video switching matrix (3) model Sierra Lassen XL, which in turn transmits them to the outputs chosen by the professionals for viewing either through the multi-channel screen (M7) or through any of the screens (M1 ... M6). To do this, the video switching matrix

(3) can be operated using a remote control (7) or a support PC (not shown). Next, 10 output PAL channels of the video switching matrix (3) are sent to the multi-image processor (4) Kaleido-Alto, which groups them into a single channel in multiple digital video format to display the 10 selected images through the multi-channel display (M7). On the other hand, the remaining 6 output PAL channels of the video switching matrix (3) are sent to the screens (M1 ... M6).

Therefore, as mentioned earlier in this document, the image seen on each of the 6 screens (M1 ... M6) can be changed at any time by the remote control (7). Thus, during the development of the intervention, each professional has in front of the most appropriate image at all times. Some professionals, such as instrumentalists, need the image of the surgical field (in order to give the material to surgeons more efficiently). Others, such as surgeons themselves, anesthesiologists or other professionals need to see in real time different images during the intervention (endoscopes, neurophysiology signals, previously obtained radiological images, or substantial safety data from the digital clinical history such as laterality, pathological studies or allergies, or respirator or ultrasound signals). In addition, other professionals, such as neurophysologists or anesthesiologists, need access to the image of the surgeon's work area. Likewise, the images that make up the multiple image output are also configurable by means of the PC or the remote control (7). An example of the use that could be given to each of the output images is as follows:

M1 Screen for surgeons.

M2 Screen for anesthesia.

M3 Screen for players.

M4 Screen for neurophysiology.

M5 Screen for public outside the operating room.

M6 Connection to web video server.

M7 Multiple digital image.

In addition, a recording device (5) stores the images corresponding to the multi-image channel and one of the channels (in this example it is the “Surgeons Screen” channel, corresponding to the M1 screen), being able to later recover these recordings for various uses , such as demonstrations, courses, seminars, etc. In this example, the recording equipment (5) consists of two professional hard disk video recorders accessible via USB port. The screen (M8) that shows the images of the channels that are being recorded both at the input and output of the recording equipment (4), and which allows access to previously stored material, has also been represented.

In addition, an audio management system (9) incorporates four inputs, two microphone (MIC1, MIC2) and two line (L1, L2), as well as two outputs (A1, A2) with line level to be connected to self-powered speakers. In addition, mixing of all audio is recorded along with the multiple image. All channels can be disabled manually.

The connection circuits of the audio management system (9) are completely independent of the connection circuits (8) corresponding to the video, as shown in Fig. 2. Also shown in Fig. 2 is the mobile platform with wheels. on which the system (1) is arranged, which is provided with a handle (10) adjustable in height to facilitate its transport by hospital staff.

Claims (14)

1. Surgical imaging analysis and management system (1), which receives 12 PAL channels and 4 VGA channels containing surgical information, characterized in that it comprises the following elements:

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a VGA / PAL conversion device (2) that converts the 4 source VGA channels into 4 PAL channels;

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a 16-channel video switching matrix (3) that receives the 12 source PAL channels and the 4 outgoing PAL channels of the VGA / PAL conversion device (2) and selectively sends them to 12 output PAL channels;

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screens (M1 ... M6) respectively connected to 6 output PAL channels of the video switching matrix (3), which allow medical personnel to visualize the corresponding images in real time;

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a multiple image processor (4) connected to the remaining 10 output PAL channels of the video switching matrix (3), which creates a multiple digital video signal containing said 10 PAL channels and sends them to a multichannel monitor ( M7) for display; Y

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a recording equipment (5), configured to store the multiple digital video image and an output PAL channel of the switching matrix (3).

2.

Surgical image analysis and management system (1) according to claim 1, further comprising a PC connected to the video switching matrix (3) and the multiple image processor (4) to facilitate its handling and configuration.

3.

Surgical image analysis and management system (1) according to any of the preceding claims, which further comprises a remote control (7) that allows medical personnel to operate the video switching matrix (3) to decide which are the images shown on the screens (M1 ... M6) and / or on the multi-channel screen (M7).

Four.

Analysis and management system (1) according to any of the preceding claims, wherein the recording equipment (5) comprises a first recording unit (G1) arranged to store an output PAL channel of the video switching matrix ( 3) and a second recording unit (G2) arranged to store the multiple digital image.

5.

Analysis and management system (1) according to claim 4, further comprising an additional screen (M8) connected to the input and output of each of the recording units (G1, G2).

6.

Analysis and management system (1) according to any of the preceding claims, further comprising an audio management system (9) with two microphone inputs (MIC1, MIC2) and two line inputs (L1, L2), as well as two outputs with line level (A1, A2) that allows real-time retransmission of surgical interventions, as well as two-way communication between the operating room and outside.

7.

Analysis and management system (1) according to claim 6, wherein the connection circuits of the audio management system device (9) are independent of video connection circuits (8).

8.

Analysis and management system (1) according to any of claims 6-7, wherein the audio input and output of the audio generation system (9) are mutable.

9.

Analysis and management system (1) according to any of claims 6-8, wherein the mixture of the different audio inputs is recorded together with the video of the multiple digital image.

10.

Analysis and management system (1) according to any of the preceding claims, characterized in that it additionally comprises a modular wiring subsystem formed by at least two cable branches collected under a pipe and terminated in connection boxes, which allows the system to be deployed Quickly and easily in unusual environments.

eleven.

Analysis and management system (1) according to any of the preceding claims, which is arranged on a transferable platform.

12.

Analysis and management system (1) according to claim 11, further comprising a handle (10) for easy transport.

13.

Analysis and management system (1) according to any of the preceding claims, wherein the multiple digital video signal is a VGA, DVI or SPI signal.

SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201030370 SPAIN Date of submission of the application: 03.15.2010 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: See Additional Sheet RELEVANT DOCUMENTS

Category

56 Documents cited Claims Affected

X

ES 2264845 B2 (UNIVERSITY OF SEVILLE) 16.01.2007, summary; page 3, line 7 - page 4, line 22; claims 1-5. 1-13

TO

MELZER A. "Technologie im Operationssaal der Zukunft - Integration bildgebender verfahren in die bildgesteuerte Chirurgie", Zentralblatt für Chirurgie, Germany, June 2008, vol. 133, No. 3, pages 197-200. 1-13

TO

PAPADEMETRIS X. et al. "From medical image computing to computer-aided intervention: development of a research interface for image-guided navigation", International Journal of Medical Robotics and Computer Assisted Surgery, United Kingdom, June 2009, vol. 5, No. 2, pages 147-157. 1-13

TO

US 2008 144906 A1 (ALLRED et al.) 06.19.2008, the whole document. 1-13

TO

US 2005 128184 A (MCGREEVY) 16.06.2005, the whole document. 1-13

TO

EP 1755059 A (GEN. ELECTRIC US) 21.02.2007, the whole document. 1-13

TO

WO 2007137115 A (STRYKER CORP.) 29.11.2007, the whole document. 1-13

TO

US 5740801 A (BRANSON) 21.04.1998, the whole document. 1-13

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 30.01.2012

Examiner A. Cárdenas Villar Page 1/4

REPORT OF THE STATE OF THE TECHNIQUE Application number: 201030370 CLASSIFICATION OBJECT OF THE APPLICATION A61B19 / 00 (2006.01) G06T1 / 00 (2006.01) G06T7 / 00 (2006.01) Minimum documentation sought (classification system followed by classification symbols) A61B, G06T Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, NPL, INSPEC, MEDLINE, BIOSIS State of the Art Report Page 2/4  WRITTEN OPINION Application number: 201030370 Date of Written Opinion: 30.01.2012 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims 1-13 Claims IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1 -13 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base.- This opinion has been made on the basis of the patent application as published. State of the Art Report Page 3/4  WRITTEN OPINION Application number: 201030370 1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

ES 2264845 B2 (UNIVERSITY OF SEVILLE) 01/16/2007

D02

MELZER A. "Technologie im Operationssaal der Zukunft - Integration bildgebender verfahren in die bildgesteuerte Chirurgie", Zentralblatt für Chirurgie, Germany, June 2008, vol. 133, No. 3, pages 197-200.

D03

PAPADEMETRIS X. et al. "From medical image computing to computer-aided intervention: development of a research interface for image-guided navigation", International Journal of Medical Robotics and Computer Assisted Surgery, United Kingdom, June 2009, vol. 5, No. 2, pages 147-157.

D04

US 2008 144906 A1 (ALLRED et al.) 06.19.2008

D05

US 2005 128184 A (MCGREEVY) 06/16/2005

D06

EP 1755059 A (GEN. ELECTRIC US) 02.21.2007

D07

WO 2007137115 A (STRYKER CORP.) 11/29/2007

D08

US 5740801 A (BRANSON) 04/21/1998

2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The patent application under study has an independent claim, No. 1, which refers to a surgical image analysis and management system containing a VGA / PAL conversion device, a video switching matrix, a series of screens visualization, multiple image processor and recording equipment. Dependent claims 2-12 refer to additional features of the system (transferable platform, equipped with handle) and of the different components. As the claims are currently drafted, especially independent claim No. 1, the patent application under study is novel but lacks inventive activity as specified in article 8 of the Patent Law. In fact, if we consider the document nº 1, cited by the applicant himself, as the closest in the state of the art, we can see that it describes a “surgical image analysis and management system consisting of a portable unit " Different imaging and signal generating devices are connected to said system and the system allows the integration and combination of the input information to facilitate its visualization (see especially page 3, line 7 - page 4, line 22). The different system components claimed in the application under study (VGA / PAL conversion device, video switching matrix - Sierra Lassen XL model type -, multiple image processor - Kaleido-Alto model -, display monitors and recording equipment ) are well known in the state of the art and, therefore, it is considered that, although the claimed system does have a novel configuration, it lacks inventive activity as specified in the article cited in the previous paragraph. The documents cited D02 - D08 reflect different aspects of the state of the art related to systems and processes of acquisition, recording, storage and visualization of surgical images and detail their main components including, among others, input devices of different types of signal, devices of display, image processors and controllers. State of the Art Report Page 4/4